Method and apparatus for compounding desired concentrations



Oct. 12, 1965 D, M. MEYSEMBOURG ETAL 3,211,431

METHOD AND APPARATUS FOR COMPOUNDING DESIRED CONCENTRATIONS Filed Sept. 27. 1961 FIG. 5

36 3B INVENTORS DAVID M. MEYSEMBOURG GEORGE E.NELSON Gail/ m 4/ W ATTORNEYS United States Patent 3,211,431 METHOD AND APPARATUS FOR COMPOUNDING DESIRED CONCENTRATIONS David M. Meysembourg, 17 13th Ave. SW., and George E. Nelson, 212 First National Bank Bldg., both of Rochester, Minn.

Filed Sept. 27, 1961, Ser. No. 141,055 Claims. (Cl. 259-12) In particular, this invention relates to method and apparatus for extemporaneously compounding a first compound of higher concentration in appropriate base ,material to provide a desired lower concentration of said first compound. More particularly, this invention relates to method and apparatus for extruding a pre-determined quantity of a desired compound into a base of known quantity and volume and mixing the base and the compound to provide a mixture of a desired concentration.

In utilizing prior art methods and apparatus for extemporaneously compounding medicinals to a desired concentration, it is necessary that the pharmacist keep in store a large number of receptacles of different concentration of a given medicinal compound in order to provide the necessary concentration of a prescribed medication. Further, to compound the desired described concentration, prior art methods involve tedious procedures. This linvention has been made to reduce the number of receptacles of different concentrations that have to be kept on hand and to provide method and apparatus for more readily extemporaneously compounding ointments or other compounds that will chemically assay within the limits required by the United States Pure Food and Drug Administration.

An object of this invention is to provide new and novel method for extemporaneously compounding the desired concentration of a medicament with a base and apparatus for carrying out said method. A further object of this invention is to provide a new and novel receptacle for facilitating the kneading or malleating a selected volume of medicant into a base. Still another object of this invention is to provide a new and novel receptacle for retaining a given quantity of base and for mixing into the base a medicinal that is extruded into said receptacle.

Other and further objects are those inherent in the invention herein illustrated, described and claimed, and will be apparent as the description proceeds.

To the accomplishment of the foregoing and related ends, this invention then comprises the features hereinafter fully described and particularly pointed out in the claims, the following description setting forth in detail certain illustrative embodiments of the invention, these being indicative, however, of but a few of the various ways in which the principles of the invention may be employed.

The invention is illustrated by reference to the drawings in which the same reference numerals relate to the same parts and in which:

FIGURE l is a cross sectional view of the receptacle of this invention having a screw type cap for retaining the base material therein;

FIGURE 2 is a fragmentary cross sectional view of the receptacle of FIGURE 1 showing the mouth portion of the receptacle together with a syringe for injecting a concentrated medicinal compound into the base contained within the receptacle;

FIGURE 3 is a transverse cross sectional view taken along the line and in the direction of the arrows 3-3 of FIGURE 1;

FIGURE 4 is a fragmentary cross sectional view of the second embodiment of the receptacle of this invention together with the cap screw therefor; and

3,211,431 Patented Oct. 12, 1965 ice FIGURE 5 is a fragmentary cross sectional view of the third embodiment of the receptacle of this invention together with removable enclosure thereof which is not shown in cross section.

Referring in particular to FIGURE 1 and FIGURE 3, there is illustrated a plastic tubular receptacle, generally designated 10, of this invention. The receptacle 10 includes a tubular barrel 11, a first end closure 12 joined to the barrel at one end thereof, and a mouth end closure 13 joined to the opposite end of the barrel. Preferably, the barrel is made of polyethylene of a thickness not less than four thousandths of an inch and not greater than approximately twenty thousandths of an inch, and of a density so that it is pliable enough to easily facilitate the mixing process described hereinafter. Of course, it is to be understood that the gauge of the plastic material and the type of material used will vary according to the application to which the receptacle is to be used.

The bottom end closure 12 has a flange portion 12a appropriately secured to the barrel by, for example, glue or heat sealed. Formed integral with the flange 12a is an inwardly projecting conical portion 12b. Preferably the angle of incidence of the conical portion, that is the angle supplementary to the angle A illustrated in FIG- URE l, is of an order of magnitude of about 60-90. An angle of 60 would be more desirable for mixing harder substances, while an angle closer to would be more desirable for substances that blend themselves more easily to homogenization by the kneading process described hereinafter.

Even though it is preferred that the inner surface of 1217 be of a conical shape and of an angle within the aforementioned range, it is to be understood that the angle might be slightly less or slightly greater depending upon the mixtures kneadableness and that the portions 12b instead of being conical may be for example, hemispheroid in shape. A purpose of providing end closures of the aforementioned shape will become more apparent hereinafter.

Appropriately adhered in the top end of the barrel 10 is the top end closure 13. A threaded aperture 14 is formed in the closure 13. For closing the aperture in the top closure there is provided cap 16 having a threaded plunger 17, the threads of the plunger forming a matching fit with the thread of the threaded aperture. The plunger is of a length and has an end portion that forms a continuation of the surface of the conical shaped surface of said closure 13, it being mentioned that the closure 13 is of an angle of the same angle as that of the closure 12.

Although the receptacle 10 may be made of various dimensions for pharmaceutical applications of the receptacle and process described herein, usually there would be provided receptacles of two different sizes. The receptacle of one size would contain in excess of 20 grams of space for the ointment base to occupy, approximate dimensions of the receptacle being one-half inch to threequarters inch in diameter and of a length of about four inches. A smaller size suitable for containing in excess of five grams of space for the base would be of one-fourth inch to three-fourth inch in diameter and of a length of about two inches. In each size receptacle it would have in addition to the space for the ointment, space for the medicinal compound to be injected thereinto. Of course, it is to be understood that receptacles may be made of different sizes to accommodate the mixing process of different quantities of base and medicinal compounds, and for the implementation of uses other than in the pharmaceutical field.

In order to inject into the receptacle the medicinal that is to be compounded in a desired concentration, there is provided a syringe, generally designated 25. The

syringe includes a tubular container 26 having an end wall 28 and a reduced diameter end portion 27 at the opposite end of the container from said end wall. The end portion 27 is of a diameter to be insertable through the aperture 14 and is of a length to extend a substantial distance inwardly into the barrel 11 beyond the apex of the top end closure 13. The end portion 27 is provided with a bore 27a that opens into the hollow interior of the tubular container.

Slidably mounted within the interior of the container 26 for forcing the contents in the container out through the bore 27a is a piston 29. Connected to the piston and extended outwardly through a central aperture formed in the end wall 28 is a handle 30. Preferably, the container 26 is provided with indicia to indicate the amount of material extruded through the end portion 27 upon moving the handle 30 in the direction of the arrow 31 and thereby moving the piston a corresponding amount in said direction.

The first embodiment of the receptacle having been described, the second embodiment of the receptacle, generally designated 35, will now be set forth. Referring in particular to FIGURE 4, the second embodiment of the receptacle generally designated 35 includes a barrel 36 having an end closure 37 mounted in one end thereof. The cylindrical portion 37a of the end closure is appropriately adhered to the inner side wall of the barrel while the conical portion 37b of said closure extends inwardly into the barrel.

Formed integrally with the opposite end of the barrel 36 is the top end closure 38 which has an axially extending aperture 39. As may be noted in FIGURE 4, the aperture opens into the hollow interior of the barrel through the apex portion of the conically shaped portion of the closure 38.

The closure 38 has a reduced diameter threaded portion 40 that extends axially outwardly from the barrel. A cap 41 having internal threads 42 is threaded on the portion 40. The cap also has an inwardly extending plunger 43 that is of a size and length to completely plug the aperture 39. The inner end of the plunger is rounded to form a matching fit with surface 38a of the end closure 38.

Through the use of blow molding plastic machinery it is possible to make the barrel and the closure 38 in one operation. With respect to both the first embodiment and the second embodiment, the end closures are made of plastic or other material that are thick enough to be of sufiicient rigidity to withstand collapse when the center of the tube is being rolled between the fingers. Further, the end closures (12 and 37) may either be hollowed out as shown in FIGURE 1 or solid as shown in FIGURE 4 as long as they have sufficient rigidity. In the event that the end pieces are made separate from the barrels to which they are attached, they are bound to the respective barrels in a separate process. The binding substance of course would have to be of a nature which would form a completely liquid-proof seal and would not deteriorate under attack by the contents of the receptacle.

The second embodiment of the receptacle having been described, the third embodiment of the receptacle, generally designated 50, will now be set forth. Referring in particular to FIGURE 5, the receptacle includes a barrel 51 having an end closure 52 adhered to one end of the barrel. The closure 52 is hollowed out on the outside and has an annular flange 52a which is appropriately joined to the barrel. The generally conical portion 52b of the closure extends inwardly into the barrel and has a surface facing into the barrel that is shaped similarly as that described for the first and second embodiments of the invention.

The opposite end of the barrel is internally threaded at 51a to form a matching fit with the externally threaded cylindrical portion 55a of the end closure 55. The closure 55 has a portion 55b having a generally conically shaped surface extending into the interior of the barrel, the shape of said surface preferably being the same as that of the surface of 52b but being oppositely faced.

A hand grip portion 55c is formed integral with portion 55a to extend outwardly from the barrel. The hand grip may be ribbed or otherwise appropriately configurated to facilitate threading the closure 55 into the barrel as shown in FIGURE 5 or removing it from the barrel. It is to be noted that the closure 55 is not provided with an aperture therein such as that of the closures of the first and second embodiments of the invention.

As an illustration of the method of this invention, normally a pharmacist would keep a stock of receptacles 10 on hand that have previously been partially filled with, for example, 20 grams of a base having none of the desired medicinal compounds therein. The pharmacist, upon receiving a prescription for a medicament of a given lower percentage other than that on stock, would unscrew cap 16 and then take a filled syringe 25 with a sufiicient quantity of the prescribed but concentrated medicament. The reduced diameter portion 27a of the syringe is then inserted through the threaded aperture 14 as is illustrated in FIGURE 2. Next, the handle 30 is moved in the direction of the arrow 31 a distance sufficient to extrude a preselected quantity of the medicament into the hollow interior of the receptacle 10. Now the syringe is withdrawn and the cap 16 is again threaded into the aperture 14 as illustrated in FIGURE 1. The medicament, in the form of a paste or other form, is extruded into the receptacle in a known volume according to the indicia on a syringe in an amount necessary to obtain the desired strength ointment. After closing the tube, the contents of the receptacle is kneaded or malleated until thoroughly mixed as will be indicated by the evenness of the color of the compounded ointment, assuming that a colored dye or other material has previously been mixed in the medicament. By providing the conical or similarly shaped end portions that are contoured to be of decreasing transverse width W along the elongated length of the barrel as said portions extend inwardly into the barrel of the receptacle, there Will not be any isolated areas of the ointment adjacent the ends of the receptacle that do not have the medicament thoroughly mixed into the base after having rolled the barrel portion of the tube between the fingers. This is one of the important features of this invention. Further, by providing a cap having a plunger completely filling the recess opening, no un-uniformly mixed material will be located in this area.

As examples of various concentrated medicaments that may be provided to be injected by syringe but not as limitations of the invention, any one of the following may be used:

(1) Neomycin ointment (2) Polymyxin ointment (3) Bacitracin ointment (4) Combinations of the above and/or including other antibiotics in the form of ointments (5) Penicillin ointment (6) Hydrocortisone ointment (7) Other corticosteroids (8) Any ointments which would be desirable in various strengths, that would lend themselves to be incorporated into a malleably viscous paste or ointment (base) and that can be extruded into a receptacle containing a pre-determined volume and weight of the malleably viscous base (i.e. that would yield the proper ointment from a medicinal point of view).

As examples of the bases that can be used, the following are set forth as being illustrative, but not as a limitation on the invention. Suitable bases are as follows:

( l) U.S.P. Hydrophylic ointment (2) U.S.P. petrolatum (3) Petrolatum, or other olcaginous bases in mixture with other solvents in order to yield a water soluble base (Washable ointment bases, more or less as may be required).

The prescribed medicament is compounded into a paste that is of a high concentration with a dye or color material added, preferably using the same base for formulating the highly concentrated medicinal as the base in the receptacle (with no medicament) into which the highly concentrated medicament is extruded. The dye may be such as will render a skin colored ointment upon mixing; however, it can be any color desired. The base used is one that in ordinary one batch strength ointments is found on the market today.

When the prescription is prepared the highly concentrated medicament in paste form in a known volume according to the indicia on the extruder is extruded into a like base (although it may be a different type base) in the amount necessary to obtain the desired strength. The tube is then closed tightly and the mixture is kneaded or malleated until well mixed as will be obvious from the completeness of the dispersion of the dye and evenness of the color of the compounded ointment.

As an example of the above process, assume that the medicament is kept in or prepared in a base to be of 45% concentration and that the prescription requires 5% concentration of the medicament. Also, assume that the receptable contains a base in the quantity of grams. In such a case, 2.5 grams of the 45% concentrated medicament (highly concentrated) is extruded into the receptacle having 20 grams of the base having no medicament. Upon thoroughly mixing the highly concentrated medicament into the base previously in the receptacle, a medication of 5% concentration of the medicament is obtained. Likewise, in the event that other concentrations are desired, the necessary amount of highly concentrated medicament can be readily calculated and extruded into the receptacle. It is contemplated that appropriate tables or graphs would be provided that show the amount of medicament of given concentration that would have to be extruded in, for example, 20 grams of base, in order to give the medicament of the desired reduced concentration.

Although the invention described heretofore has been with respect to usage in the pharmaceutical field, it is to be understood that the method and apparatus may be used in other fields upon making the receptacle and a syringe of an appropriate size or device performing a similar function. As examples of other fields in which the method and apparatus of this invention may find utility, the fol lowing are set forth:

(1) Dental cements of varying solidifications.

(2) Medicine and veterinary medicine for extemporaneously mixing ointments and salves.

(3) Toothpaste in varying prescribed strengths as well as in varying flavors for the consumer market.

(4) Food mixing: Solid oil, cake icings, pancakes and cake instant mixes, prepowdered baking mixtures, etc.

(5) Cosmetic mixing; powders, rouges, etc.

(6) Artistic painting oils in varying degrees of brilliance.

With respect to utilizing the apparatus and method of this invention for mixing in accordance with the list set forth in the preceding paragraph, it is contemplated that normally the base material will be in a viscous form that can be readily kneaded and that the other compound is extrudable into the receptacle of this invention in a viscous form such as a paste or a liquid. Likewise, it is contemplated that the material which may be extruded by a syringe into the receptacle will contain appropriate dye or coloring material to indicate when the base plus the material extruded into the base is thoroughly mixed.

Assuming that a receptacle of this invention is to be used for food mixing, then preferably the third embodiment is used since it has a wide mouth. The receptacle 50 would normally be sold to the housewife with a quantity of premixed ingredients therein. When it is desired to use the food mix in the receptacle, the closure 55 is removed and then, for example, the desired quantity of milk is added. The amount to be added may be indicated by appropriate indicia on the barrel 51. After the ingredients are added, the closure is again threaded into the barrel and the barrel portion is kneaded or malleated with the hands to thoroughly mix all ingredients in the receptacle.

As many widely apparently different embodiments of this invention may be made without departing from the spirit and scope thereof, it is to be understood that we do not limit ourselves to the specific embodiments herein.

What we claim is:

1. A receptacle for compounding materials comprising an axially elongated, flexible tubular barrel, a first closure for one end of the barrel joined to said one end of the barrel, a second closure joined to the opposite end of the barrel, each of said closures having surface portions extending into the interior of the barrel, each of said surface portions being contoured to be of an increasing transverse width from the part most closely adjacent the opposite closure axially toward the respective end of the barrel to the location that the respective closure contacts the barrel, said second closure having an opening therethrough opening into the interior of the tube for permitting filling the tube and means removably secured to said second closure for closing said second closure opening.

2. The apparatus of claim 1 further characterized in that said closure surface portions are of generally conical contour.

3. The apparatus of claim 1 further characterized in that the contour of each closure surface portion is such that the angle of incidence of their surfaces with a plane coextensive with the elongated axis of the tube is between about to and each closure includes a cylindrical surface portion having an outer diameter to abut against the barrel, each cylindrical surface portion being joined to the respective first mentioned portion to extend in a direcion away from the opposite closure.

4. The apparatus of claim 1 further characterized in that said means includes a plunger having an inner end surface generally coextensive with the surface of the second closure when said means is secured to said second closure for closing the second closure opening.

5. A receptacle comprising an elongated flexible plastic barrel, a first closure secured to one end of said barrel for closing one end of said barrel, a second closure secured to the opposite end of said barrel for closing said opposite end, said closures each having curved surfaces extending into the interior of the barrel toward one another, said surfaces being contoured to approach the elongated axis of the barrel as they extend further inwardly into the interior of the barrel, one of said closures having an access aperture opening into the interior of the barrel and means removably secured to said one closure for closing said aperture.

6. The apparatus of claim 5 further characterized in that said closure aperture is threaded and that said means comprises a cap having a threaded plunger portion having threads that form a matching fit with the threaded aperture.

7. The apparatus of claim 5 further characterized in that said one closure has an externally threaded portion and that said means comprises a cap having a plunger of a size to fill said aperture both axially and in cross section and an internally threaded portion having threads that form a matching fit with the closure threaded portion.

8. The method of extemporaneously compounding a desired concentration of an extrudable medicament from a more highly concentrated medicament into a maleable medicament base in a flexible tubular cappable receptacle having end closures extending inwardly into the interior of the receptacle to preclude isolation portions of the base adjacent the ends of the receptacle being unevenly compounded comprising providing in the receptacle a given quantity of base, syringingly injecting a kno 1- ume of the higher concentrated medicament into the re ceptable, capping the receptacle and kneading the receptacle to thoroughly mix the higher concentrate medicament into the base to provide a medicament of a lower known concentration.

9. A receptacle for compounding a kneadable material comprising an elongated flexible barrel, a first closure joined to one end of said barrel for closing said end of said barrel and means mounted on the opposite end of the barrel for alternately providing access to the interior of the barrel and closing the access to the interior of the barrel, said first closure and said means each having curved surfaces extending into the interior of the barrel toward one another, said surfaces being contoured to approach the elongated axis of the barrel as they extend further inwardly into the barrel.

10. The apparatus of claim 9 further characterized in that said opposite end of the barrel is threaded and that said means includes a threaded portion forming a rnatching fit with the barrel threads for removably securing said means to the barrel, said closure and said means being of sutficient rigidity to withstand collapse when the barrel is manually kneaded.

References Cited by the Examiner UNITED STATES PATENTS WALTER A. SCHEEL, Primary Examiner.

LEO QUACKENBUSH, Examiner. 

1. A RECEPTACLE FOR COMPOUNDING MATERIALS COMPRISING AN AXIALLY ELONGAGED, FLEXIBLE TUBULAR BARREL, A FIRST CLOSURE FOR ONE END OF THE BARREL JOINED TO SAID ONE END OF THE BARREL, A SECOND CLOSURE JOINED TO THE OPPOSITE END OF THE BARREL, EACH OF SAID CLOSURES HAVING SURFACE PORTIONS EXTENDING INTO THE INTERIOR OF THE BARREL, EACH OF SAID SURFACE PORTIONS BEING CONTOURED TO BE OF AN INCREASING TRANSVERSE WIDTH FROM THE PART MOST CLOSELY ADJACENT THE OPPOSITE CLOSURE AXIALLY TOWARD THE RESPECTIVE END OF THE BARREL TO THE LOCATION THAT THE RESPECTIVE CLOSURE CONTACTS THE BARREL, SAID SECOND CLOSURE HAVING AN OPENING THERE THROUGH OPENING INTO THE INTERIOR OF THE TUBE FOR PERMITTING FILLING THE TUBE AND MEANS REMOVABLY SECURED TO SAID SECOND CLOSURE FOR CLOSING SAID SECOND CLOSURE OPENING. 